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New Diet Pill from Two Old Drugs
Posted: Wednesday, September 16, 2009
Patients taking a novel diet drug that combines the stimulant phentermine with the anticonvulsant, topiramate lost an average of 37 pounds over a year with significant improvement in a number of cardiovascular risk factors.
In EQUIP, a phase III, placebo-controlled trial of more than 1,200 morbidly obese patients, those randomized to the drug, which has the brand name Qnexa, lost weight at every tested dose, but significant weight loss -- 14.7% on average (P<0.0001 versus placebo) -- occurred at the highest dose. Moreover, when an intention-to-treat analysis was performed, the average weight loss dropped to 11%, (P<0.0001 versus placebo).
In a second phase III trial, CONQUER, which enrolled 2,487 overweight and obese patients with hypertension, hyperlipidemia, or Type 2 diabetes, the average weight loss was 30 pounds with the full dose (15 mg phentermine/92 mg topiramate), which was also highly significant (P<0.0001 versus placebo).
When asked for a comment on the scant data reported by the drugmaker, Mitchell Roslin, MD, of Lenox Hill Hospital in New York City, called the results very impressive, noting that the reported weight loss approached that of the Fen-Phen combo drug that swept the diet market in the early 1990s.
But Fen-Phen fell as fast as it rose when fenfluramine, which was the "Fen" in Fen-Phen, was linked to pulmonary hypertension and serious heart valve problems, leading to the drug's withdrawal from the market amid an avalanche of lawsuits.
Phentermine, a stimulant that acts as an appetite suppressant, has remained on the market, although as Roslin said, "It can increase blood pressure or make people feel jumpy."
Carl J. Lavie, MD, of the Ochsner Heart and Vascular Institute in New Orleans, also raised the caution flag about cardiovascular side effects of phentermine, which he said also has the potential to "cause rhythm disturbances."
Topiramate is best known as an epilepsy drug, but Roslin said that it gained off-label traction when several published studies suggested the anticonvulsant had a beneficial "effect on binge eating and weight reduction." But Roslin said at least one company decided against pursuing a weight loss indication for topiramate when clinical trials found that while the drug did help people shed pounds, side effects included drowsiness and memory problems. "Thus the results of the combination are impressive," Roslin said.
Lavie, agreed, noting that obesity itself is a major cardiovascular risk factor and the weight loss reported in EQUIP and CONQUER was "generally more than is typically reported with other nonsurgical therapies."
But a number of questions were left unanswered by the topline data released by Vivus (the manufacturer) including whether rebound will occur when the drug is stopped. Short-term safety looked good, Roslin said, but if long-term use is needed to maintain weight loss, safety could become an issue.
Leland Wilson, president and CEO of Vivus said that based on the results from the EQUIP and CONQUER trials, which were "designed and executed after Special Protocol Assessments were completed by the FDA," the company will file a New Drug Application with the FDA by the end of this year.
Source: Diabetes In Control: From Vivus, the developer of the drug.
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